Edentulous specific support and aesthetic restorative appliance

ABSTRACT

An edentulous mouth insert appliance for mounting upon the edentulous gum of a patient, comprises a u-shaped frame formed of a rigid flexible material, with a portion to embrace the gum and a portion extending beyond the gum with an exposed surface to replicate a bite aligned with the corresponding occlusal plane. The frame has a base supporting a pair of inner and outer side walls spaced apart by the base a distance allowing the frame to encircle and cover the edentulous gum with a space between inner surfaces of the frame and the gum. A fill within the frame fills the space between the frame and the gum upon which the appliance is fitted, providing a void-free seal between the apparatus and the gum.

FIELD OF THE INVENTION

The present invention is directed to a periodontal appliance for anedentulous (teeth-lacking) patient. In particular it is directed to anappliance to interface with a patient's maxilla or mandible fullywithout teeth being present on the ridge. The appliance is designed tohave an outer shape of the mandibular and maxilla structure to which itis attached to provide aesthetic and functional improvement in theedentulous oral cavity and to restore natural facial appearance, basicmechanical functionality, and enhanced oral hygiene applications. Thenew appliance is not a temporary or permanent replacement for teeth, asan edentulous ridge or oral cavity has a unique anatomical structure andpathology that must be addressed to restore and maintain enhancedgeneral and oral health.

BACKGROUND OF THE INVENTION

An exponential growth of the edentulous population is forecasted toaffect 200 million Americans within 15 years; global prosthodontics andmedical experts have documented the severity of the issue and concludeexisting edentulous hygiene methods and education are not effective.Elderly and immune-suppressed edentulous patients in particular needaccess to a sterile appliance in order to decrease morbidity and otherserious health defects.

Flexible rubber and plastic universal mouthpieces are designed toprovide protection for the teeth during contact sports. Medical grademouthpieces are commonly used to protect the teeth from grinding(bruxism), in addition to providing any number of cosmetic and healthrelated benefits for a dentally correct mouth; all have a primaryfunction of enhancing or interfacing with a set of teeth.

The existing art for mouthpieces and guards with utility only applicableto teeth is extensive; most cannot accommodate braces but all requireand function with at least one set of teeth. Improvements of the artinclude new methods and structures for enhanced shock absorption toprevent injuries to the teeth and mouthpieces to be used in conjunctionwith processes for teeth whitening and teeth straightening. All of theart shares the commonality that they are intended to improve or protectnatural teeth in some form, are typically molded and anchored to theteeth for a custom fit and retention; they all require teeth and arecompletely incompatible with an edentulous mouth.

The edentulous mouth cannot accommodate the existing art, nor benefitfrom the intended use for protection or maintenance of mouthpiecescommon to a user with healthy teeth. The anatomy of an edentulouspatient is medically and anatomically unique, requiring specialized andunique dimensions and features designed to meet the parameters and needsof the edentulous user.

For the edentulous patient, conventional dentures provide for arealistic looking prosthetic appliance to replace the teeth, typicallycomprising at least a hard composite pallet body and realistic acrylicteeth.

There are two primary functions of a removable denture; to provide anaesthetically realistic and functional replacement of the teeth and toallow for mastication of solid foods. It is designed to adhere tightlyto the gingivae, typically with an adhesive to create a seal, and allowsfor typical mastication of solid food. It is considered a prostheticappliance. While its primary function is to replace and providerealistic teeth, studies have concluded that sealing the gum anddepriving it of oxygen can damages the gingivae; healing of the gingivaeis not possible without exposure to oxygen.

Edentulous bone and ridges naturally shrink and melt away. The use ofconventional dentures has been proven to increase the progression ofthis chronic issue; eventually the ridge line and especially themandibular ridge completely reabsorb into the jawbone. Without teeth tostimulate bone growth this deterioration results in a unsightly sunkenface, and leaves the edentulous patient permanently disfigured, whichseriously impedes quality of life. Both short and long term tissuedamage is a negative side effect of extended denture use and isindicative of a greater risk to general health.

A 25-year-long study published in 1972 by Dr. Antje Tallgren of theRoyal Dental College in Denmark concluded “denture wearers havecontinual bone loss; the biting force on the gum tissue irritates thebone and it melts away decreasing in volume and density.”

The rate of reduction in size of the residual ridge is maximum in thefirst three months and then gradually tapers off The bony remodelingthat subsequently takes place occurs in two phases: an initial andfairly rapid phase that can be observed in the first 3 months and thesubsequent slow, minimal yet continuous resorption.

During the initial period there is new bone formation with loss ofalmost all of the alveolar crest height and simultaneous reduction ofapproximately two-thirds of the ridge width. These changes continue overthe initial ten to twelve week periods.

Between six and twelve months, part of the new laid-down bone undergoesfurther remodeling resulting in the further reduction of the alveolarridge width until it is reduced to approximately half.

The rate of resorption then slows down to minimal levels and continuesthroughout life, resulting in loss of varying amounts of jaw structure,finally leaving the patient a ‘dental cripple’. This phenomenon is knownas Residual Ridge Resorption (RRR). The American Dental Association(ADA) advises patients to remove dentures at bedtime to promote tissuehealing and related health issues. The gums cannot breathe through asealed denture; oxygen is required for healing the gums.

In addition to bone resorption, there are other potentially seriousgeneral health issues that can arise due to denture use.

Denture plaque (DP) is defined as a dense microbial layer comprised ofmicroorganisms and their metabolites. It may contain more than 1011organisms per gram in wet weight and has essentially the same structureas dental plaque on natural teeth. The composition of these microbialflora also resembles that of dental plaque, except for an increasednumber of Candida spp. Candida biofilm on dentures leads to a decreasein the bacterial diversity and then to a qualitative change in thecomposition of the oral microbiota.

DP containing Candida can give rise to denture-induced stomatitis, rootcaries, and periodontitis. In addition, if the oral mucosa is weakened,the friction of the prosthesis can facilitate the breaking of theepithelial barrier and increase the risk of the passage of germs intothe bloodstream.

Moreover, the continuous swallowing or respiration of microorganismsfrom DP exposes patients, particularly the immune compromised host orpolymedicated elderly, to the risk of unexpected infections.

Dentures may present a putative risk of infection, especially forpatients with lung and digestive diseases. It seems important to preventthis risk by means of information and patient education. Patientawareness of the nature of the risk and its consequences should improvethe control of prosthetic biofilm and reduce infection rates. (18)

Other health concerns, including increases in certain oral cancers,increased pneumonia risk for users who wear their dentures during sleep,are associated with denture use.

Accordingly it is a purpose of the present invention to serve as reliefappliance for a conventional denture, intended for use on the gingivae.The use of the appliance in tandem with a denture can provide for asignificant and immediate reduction in exposure to denture plaque buildup and denture adhesives.

A further purpose of the present invention is to provide an alternativeto a conventional denture for the edentulous user, providing comfort andperiodontal benefit. It is not intended for mastication or to be arealistic replacement of functional teeth.

Yet a further purpose is to provide an oral appliance for the edentuloususer that compensates for lost human skeletal face and jaw structure.

BRIEF SUMMARY OF THE INVENTION

The present inventive subject matter comprises an inner mouth supportappliance designed to accommodate the anatomically unique structure ofan edentulous user. It is worn on top of the gum arch on the mandibularor maxilla ridge and is primarily intended for use by a completelyedentulous patient. It provides for an alternate temporary applianceused for comfort, support, and rapid replacement when a denture isunavailable or undesired, and can be used as a remedy for damage anddiscomfort that may be caused from denture use. The invention hasfurther utility in oral surgery situations, especially needed for thetreatment in facial trauma. The appliance is not intended to perform achewing task or mastication of any form, in contrast to dentures orimplants.

The appliance compensates for the negative space caused by lost bone andteeth structure, providing the anatomically correct support necessaryused to maintain natural facial appearance and speech, prevents jawfatigue, and absorbs bone-damaging pressure resulting from bite force.

The new appliance comprises a horseshoe or “U” shaped frame, formed ofan appropriate such as a rigid yet flexible anti-microbialhypoallergenic material, such as a plastic, polymer or rubbercomposition. The substrate may include an extended rigid outer extensionthat compensates for missing teeth structure and helps maintain speechfunctionality.

The frame carries a moldable liner which fills the interior of the frameand provides contact and a seal between the frame and the gum.

The frame is constructed to seat directly on the gingivae of the maxillaor mandible arch by use of the liner. The frame conforms and adheres tothe shape of the gum arch, maintaining placement and retention. Itadditionally compensates for structural support, normalized speech, andincreased quality of life for the end user.

Mendicants can be infused or applied to the interior of the base anddelivered to the gingivae for additional relief and repair.

BRIEF DESCRIPTION OF THE DRAWINGS

A fuller understanding of the present invention will be obtained uponconsideration of the following detail description thereof when taken inassociation with the annexed drawings, wherein:

FIG. 1 illustrates a side view of a healthy skeletal dental structure ina side profile;

FIG. 2 illustrates an edentulous skeletal side view without any lowerteeth present;

FIG. 3 illustrates the edentulous skeletal structure depicted in FIG. 2with the appliance of FIG. 3 seated on the lower mandible gum line orridge side profile;

FIG. 4 is a perspective view of a frame for a maxillary embodiment ofthe invention;

FIG. 5 is a generalized sectional view depicting an appliance in placein a patient's mouth;

FIG. 6 is a perspective posterior view of an alternative embodiment ofthe invention; and

FIG. 7 is a further perspective view of the alternative embodiment;

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a side view of a healthy skeletal dental structure. Thephysiologically correct jaw has normal structural spacing 104 betweenthe mandible 100 and the maxilla 102 when the upper teeth 106 and lowerteeth 108 are present. It is to be compared with the jaw orientationdepicted in FIG. 2 , which illustrates an edentulous skeletal structurewith no lower teeth present. When the lower teeth are extracted ormissing, the upper teeth 106 naturally impinge upon the lower gum line110, creating irritation, bone loss, discomfort, and a visible collapsedjaw. The triangle 112 in FIG. 2 represents a negative space, which lacksthe presence of the lower teeth. This existence of the space causesdiscomfort and skeletal muscular tension, as well as outer facialdisfigurement. The present invention “recovers” the space and replicatesthe occlusal platform that disappears in an edentulous individual.

FIG. 3 presents a simplified side profile diagram of an appliance inaccordance with the present invention in a mandibular edentulous mouth.The appliance seats on the lower mandible gum line or ridgeline. Withthe lower portion 114 of the appliance seated directly on the toothlesslower mandible arch of the gum, the extended height of the appliance'supper portion 116 compensates for the missing teeth. With the appliancein place the jaw and skeletal structure is structurally supported. Thenegative space 112 of FIG. 2 is eliminated and the mandible is returnedto its natural position. The jaw's skeletal structure is physiologicalcorrected and supported by the appliance. It is to be understood that acorresponding appliance can be seated on the upper maxillary gum, eitherin tandem with a mandible-placed appliance or by itself. Thus it is tobe understood that the following description illustrating the inventionis fully applicable to both mandibular and maxillary embodiments.

FIG. 4 presents an illustrative construction of the frame of theappliance invention contoured for maxillary mounting. Frame 120 isformed of a generally rigid plastic, polymer or rubber, shaped to fitloosely over the gingiva or alveolar ridge of the maxilla. A similarconfiguration is used for mandibular fitting. The frame is generallyu-shaped in cross-section, forming a channel with inner and outer walls122, 124 joined by base 126. The frame is preferably dimensioned suchthat the walls extend rearwardly or proximal in the mouth to locationjust forward of the position of the first or second molars. However,depending on the specific patent situation, it may alternatively extendover the molar locations. Thus the front-to-back length of the frame istypically on the order of 25-50 mm, while the wall thickness istypically in the range of 1-2 mm. The frame is flexible, and requiresonly a loose fit over the gingiva. Accordingly, it is possible for thereto be a “one size fits all” construction. Alternatively, frames can bestocked in a small number of sizes. The overall front-to back length ofa stock frame can be easily shortened or otherwise further adjusted tothe patient by trimming. Further, when faced with a particular patientsituation, an individualized frame may be formed by a suitable moldingprocess as known in the art, based on an impression of the gingiva onwhich it is to be mounted. Typically the frame may be manufactured by athermoforming or injection molding. The frame's channel may be narrowedtowards the anterior to conform to the normal narrowing of the gingiva.Typically the rear or proximal end of the channel has a width of 15-30mm. In this embodiment the frame is of a unitary construction, andcomprises a first (upper) portion corresponding to portion 114 in FIG. 3that fits around the gingiva or alveolar ridge and a second (lower)portion corresponding to portion 116 in FIG. 3 that replicates theocclusal platform lost by the removal of the teeth.

The exterior surface of the lower portion may be molded or incised tosimulate the appearance of teeth, and thus may be colored or tinted toreplicate the color of teeth. Appropriate portions of the exteriorsurface of the upper portion may likewise be tinted to replicate thecolor of the gingiva.

As depicted in FIG. 5 , fitting of the frame to the gingiva isaccomplished by the presence of a fill 132 of a suitable pliablematerial. The fill is preferably a moldable, bio-compatible, self-curingcompound, such as polyvinyl siloxane (PVS) as known in the art,typically used for dental impressions. Cellulose gum and polyethyleneglycol may also be considered as a fill or lining material. PVS is aputty or dough-like addition-reaction silicone elastomer material,comprising a base and a catalyst provided in separate containers. Whenthe base and catalyst are combined, the curing mechanism in the base isactivated. The putty hardens and becomes rigid following a 2 to 5minutes curing time.

The compound is placed within the frame in the uncured state, and curesand molds to the precise contours of the wearer's gingiva 140 when theappliance is initially placed in position and held to cure. Because theframe has some degree of flexure, it can be held in the proper positionwith respect to the gingiva as the fill layer cures. The cured layerretains the molded shape and thus insures a precise fit upon subsequentinsertion of the appliance.

The fill material may contain medication-dispensing functionalityincluding anti-inflammatory, antibiotic, and/or numbing agents such asbenzocaine. Depending on the specific formulation of the fill material,the medication may be incorporated directly into the material or may beprovided in a film form or in pockets or cavities incised into the fillafter cure.

After the PVS or other fill material is activated, it is placed alongthe floor and inner side walls of the frame. The appliance is thenplaced on the corresponding upper or lower gingival ridge. The userbites down against the opposing ridge of teeth, if present, or positivepressure is applied by the installer to position the appliance in itsproper position. Due to the flexibility of the frame, it can be pinchedto provide better conformance to the gum upon which it is being mounted.

As depicted in FIG. 4 , a cutout portion or depression 136 may beprovided on the interior wall of the anterior portion of the frame thatsurrounds the gingiva to enhance adhesion between the fill and theframe. Excess fill flow can exit through the cutout and be excised aftercure to provide a smooth frame exterior. Alternatively, as portion ofthe exited fill may be retained. The mouth-contacting surface of theexited fill may by initially shaped to the contours of the mouth by thewearer's tongue, and subsequently trimmed upon cure. In the maxillaryversion in particular the exterior flow can be contoured while pliableto rest upon the palate, which may enhance comfort and fit for theappliance.

In addition to the depression 136, the frame may be provided withdepressions or apertures 134 in the frame's base 126 to enhance bondingof the fill to the base. Likewise, fill-bonding depressions or apertures130 in the frame's inner wall may be provided. Excess fill extendingbeyond the outer surfaces of the frame can be removed after cure.

Once the fill is cured, the impression of the user's gingival ridge andsurrounding area become permanent. The rigidity of the cured fill nowlocks the previously flexible frame into a static width conforming tothe individual contours of the gingival ridge upon which it is applied.

The height of the frame, in conjunction with the degree of fill 132 arechosen such that, with the appliance in place on the gum, the plane ofthe base is aligned with the corresponding occlusal plane as illustratedin FIG. 3 , which is an imaginary curved plane formed by the incisaledges of the (missing) anterior teeth and the occlusal surfaces of theposterior teeth. This orientation mimics a proper anatomical biteregistration and provides both an attractive appearance and a normalmouth feel for the user. Typical heights for the fill 132 range between18 and 22 mm, corresponding to a fill volume of about 5-15 ml.

As stated above, similar constructions are utilized for both mandibularand maxillary constructions. For maxillary use the overall width of theappliance ranges from about 25 to 50 mm, corresponding to the size ofthe wearer's jaw, while mandibular constructions may have an overallwidth of between 25 and 55 mm.

FIGS. 6 and 7 depict an alternative embodiment for the invention. Inthis embodiment the tooth-replicating portion may be a solid structure,such that the cavity 156 into which the fill placed is formed only inportion 150. In such a case the amount of fill needed will be lessened.The gum-overlying portion 150 and tooth-replicating portion 152 may beindividually cast, typically in an overmolding process as known in theart. Alternatively, a single cast may be used, or the two portionsindividually cast and subsequently bonded together. As shown, thetooth-replicating portion 152 is shown with a width substantially lessthan that of the gum-overlying portion. The width ratio is a variablethat can take into account the size and geometry of the mouth as well asthe desired appearance and aesthetic effect. Use of a two partconstruction may facilitate the coloring of the portions, whereby thegum—overlying portion material can be dyed an appropriate pink color,while the teeth-overlying portion can be of an appropriate white,off-white or ivory color. The illustrated construction should not beconstrued as preventing such an embodiment from having both portions 150and 152 from having identical widths, as shown in FIG. 4 of the firstembodiment.

Inner wall 154 of gum-overlying portion 150 retains the a central cutout1136 to provide an outlet for excess fill material, while adjacent slots158 improve the flexibility of the appliance for proper fitting on thegum. As an alternative to the generally larger bores as shown in thefirst embodiment, the fill-bonding bores 134 in the present embodimentmay be more numerous and significantly smaller. The purpose remains thesame, however; to provide a bonding mechanism between the fill andframe.

FIG. 6 further depicts in phantom the inclusion of insert 160 imbeddedor otherwise cast into the outer wall of frame portion 150. Typically inthe form of a stainless steel wire as known in the dental arts, theinsert provides allows the appliance to be gently bent into a desiredarch configuration and retained there by the insert's rigidity. Theinclusion of the insert may facilitate the fitting of the appliance tothe gingiva during fill cure.

The insert can extend about the entre frame periphery, and be located oneither (or both) of the frame walls, or may extend over one or moreportions of the wall(s). Alternatively, a thin metal strip may beincorporated. In either event, the insert is chosen to be flexible butwith sufficient rigidity to maintain an orientation after being bent.

While the appliance of the present invention is primarily intended forfitting by a medical or dental professional, both as an emergencyreplacement as well as in connection with oral surgery or for permanentuse for an edentulous patient. It can also be offered as a kit to aconsumer, preferably for one-time use as an emergency replacement for alost or damaged denture, and be provided as an unfilled frame and aquantity of PVS or other fill material with instructions for filling theframe and molding it to the gingiva. A supplied fill volume of about 25ml is typically sufficient.

What is claimed is:
 1. An edentulous mouth insert appliance for mountingupon a fully edentulous gum of a patient, the edentulous mouth insertappliance comprising: a frame to cover the fully edentulous gum with aspace between inner surfaces of the frame and the gum; wherein the frameis structured to receive a curable material in the space between theframe and the gum to provide a seal between the edentulous mouth insertappliance and the gum.
 2. The edentulous mouth insert applianceaccording to claim 1, wherein the frame includes a base and a pair ofinner and outer side walls spaced apart by the base; and the frame isstructured to receive the curable material to position the appliance onthe gum such that an outer surface of the base is oriented at a levelcorresponding to a gingival margin of the gum with an outer surface ofthe base aligned with a corresponding occlusal plane.
 3. The edentulousmouth insert appliance according to claim 1, wherein the frame includesa base and a pair of inner and outer side walls spaced apart by thebase; and portions of outer surfaces of the outer side walls are incisedto replicate the appearance of teeth.
 4. The edentulous mouth insertappliance according to claim 3, wherein portions of the outer surfacesof the outer side walls are colored to replicate the appearance of atleast one of teeth or natural gums.
 5. The edentulous mouth insertappliance according to claim 1, wherein the frame incudes at least oneof an aperture or a cutout portion.
 6. The edentulous mouth insertappliance according to claim 1, wherein the frame is formed from amaterial selected from a group consisting of plastic, composite, andrubber medical grade materials.
 7. The edentulous mouth insert applianceaccording to claim 1, further comprising a medicament associated withthe curable material for release when the appliance is worn.
 8. Theedentulous mouth insert appliance according to claim 7, wherein themedicament is incorporated into the curable material.
 9. The edentulousmouth insert appliance according to claim 1, wherein the frame includesa securance structure to secure the curable material to the frame. 10.The edentulous mouth insert appliance according to claim 9, wherein thesecurance structure includes at least one of an aperture or a bore inthe frame.
 11. The edentulous mouth insert appliance according to claim1, wherein the frame includes an insert to facilitate retaining theframe in a desired flexed orientation.
 12. The edentulous mouth insertappliance according to claim 11, wherein the insert includes a wireembedded in the frame.
 13. The edentulous mouth insert applianceaccording to claim 1, wherein the frame includes a base and a pair ofinner and outer side walls spaced apart by the base; and a thickness ofeach of the base and the inner and outer walls of the frame is in arange of 1 mm to 2 mm.
 14. The edentulous mouth insert applianceaccording to claim 1, wherein the frame includes a portion that projectsupwardly from the base a distance such that, with the curable materialpositioning the appliance on the gum in alignment with a gingival marginof the gum, a top surface of the portion is aligned with a correspondingocclusal plane.
 15. A kit for an edentulous mouth insert appliance formounting upon a fully edentulous gum of a patient, the kit comprising: aframe to cover the fully edentulous gum with a space between innersurfaces of the frame and the gum; and a curable material, to be placedwithin the frame to be located between the frame and the gum to providea seal between the edentulous mouth insert appliance and the gum. 16.The kit according to claim 15, wherein the curable material includes abase and a catalyst; and when the base and the catalyst are combined, acuring mechanism in the curable material is activated such that thecurable material hardens following a curing time.
 17. The kit accordingto claim 15, wherein the curable material is to be placed within theframe in an uncured state and provides the seal between the edentulousmouth insert appliance and the gum when the curable material has cured.18. The kit according to claim 15, wherein the frame includes a base anda pair of inner and outer side walls spaced apart by the base; and whenthe curable material provides the seal between the edentulous mouthinsert appliance and the gum, the curable material positions theappliance on the gum such that an outer surface of the base is orientedat a level corresponding to a gingival margin of the gum with an outersurface of the base aligned with a corresponding occlusal plane.
 19. Thekit according to claim 15, wherein the frame includes a portion thatprojects upwardly from the base; and when the curable material providesthe seal between the edentulous mouth insert appliance and the gum, atop surface of the portion of the frame is aligned with a correspondingocclusal plane.
 20. An apparatus for mounting an edentulous mouth insertappliance upon a fully edentulous gum of a patient, the apparatuscomprising: a curable material to be placed in a space between a frameand the fully edentulous gum to provide a seal between the edentulousmouth insert appliance and the gum; wherein the frame covers the fullyedentulous gum with the space between inner surfaces of the frame andthe gum.